U.S. patent number 7,110,828 [Application Number 10/099,550] was granted by the patent office on 2006-09-19 for intravascular electrode line.
This patent grant is currently assigned to Biotronik Mess-und Therapiegeraete GmbH & Co.. Invention is credited to Gernot Kolberg, Max Schaldach, deceased, Max Schaldach, Jr., legal representative.
United States Patent |
7,110,828 |
Kolberg , et al. |
September 19, 2006 |
Intravascular electrode line
Abstract
An intravascular electrode line is provided with a shaping
suitable for fixing in a blood vessel. The shaping is
three-dimensional and has line portions enclosing an elongated
hollow space, with a pitch direction that is different in relation
to the longitudinal direction of the hollow space.
Inventors: |
Kolberg; Gernot (Berlin,
DE), Schaldach, Jr., legal representative; Max
(Berlin, DE), Schaldach, deceased; Max (Erlangen,
DE) |
Assignee: |
Biotronik Mess-und Therapiegeraete
GmbH & Co. (Berlin, DE)
|
Family
ID: |
7679029 |
Appl.
No.: |
10/099,550 |
Filed: |
March 15, 2002 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20020169492 A1 |
Nov 14, 2002 |
|
Foreign Application Priority Data
|
|
|
|
|
Mar 21, 2001 [DE] |
|
|
101 14 725 |
|
Current U.S.
Class: |
607/126;
607/127 |
Current CPC
Class: |
A61N
1/056 (20130101); A61N 1/057 (20130101); A61N
2001/0585 (20130101) |
Current International
Class: |
A61N
1/05 (20060101) |
Field of
Search: |
;607/119,122,123,125-128 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Evanisko; George R.
Attorney, Agent or Firm: Hahn Loeser & Parks LLP
Cunniff; John J.
Claims
What is claimed is:
1. A medical lead comprising at least one electrode and an
intravascular electrode line adapted to carry the at least one
electrode, the electrode line comprising a shaping suitable for
fixing in a blood vessel, wherein the shaping is three-dimensional
and comprises first and second coiled line portions connected in
series and defining an elongated hollow space, wherein said first
and second coiled line portions have different pitch directions in
relation to the longitudinal direction of the hollow space, wherein
the electrode line is adapted such that the walls of the blood
vessels as far as possible should not be damaged and wherein the
electrode line is adapted to bear against the walls of a blood
vessel in the region of the first and second coiled sections.
2. The medical lead of claim 1, wherein said first and second line
portions are shaped helically and which differ from each other by
an opposite rotational direction in their pitch direction.
3. The medical lead of claim 1 , wherein said first and second
coiled line portions comprise two helically shaped line portions
which differ from each other by the direction of a component of
extent of the electrode line, in parallel relationship with a
longitudinal axis of the enclosed hollow space.
4. An intravascular electrode line, comprising a shaping suitable
for fixing in a blood vessel, wherein the shaping is
three-dimensional and comprises first and second coiled line
portions connected in series and enclosing an elongated hollow
space, wherein said first and second coiled line portions have
different pitch directions in relation to the longitudinal
direction of the hollow space, wherein the coiled line portions
enclosing a hollow space comprise a wrapped .OMEGA.-shape around
the hollow space.
5. The medical lead of claim 1, further comprising a lumen within
the electrode line adapted for the insertion of a control means,
wherein the electrode line is three-dimensionally pre-shaped and
can be straightened by the insertion of a stiletto into the
lumen.
6. The medical lead of claim 1, further comprising a lumen for the
insertion of a control means, wherein the electrode line is
fiexurally soft and is three-dimensionally deformable by the
insertion of a pre-shaped stiletto.
7. The medical lead of claim 1, further comprising a sleeve which
encloses a stiffening coil of elastic material which is formed from
a plurality of turns and which in turn encloses a lumen, wherein a
Fiber is arranged in the lumen of the electrode line and fixed with
a distal end of the fiber in such a way that a force can be
produced in the electrode line, said force acting in the
longitudinal direction of the electrode line and upsetting the
electrode line, and wherein the elastic material forming the turns
of the coil is shaped in such a way that the electrode line is
three-dimensionally deformed when the fiber is tightened and the
upsetting force is acting.
8. The medical lead of claim 1, further comprising a memory metal
element which changes its shape from a first predetermined shape to
a second predetermined shape when a jump temperature is exceeded,
wherein the first shape of the memory metal element corresponds to
a substantially straight electrode line and the second shape
results in a three-dimensionally deformed electrode line.
9. The medical lead of claim 8, further comprising a heating
element for heating the memory metal element to the jump
temperature.
10. The medical lead of claim 1, wherein said at least one
electrode is for receiving and/or delivering electrical signals
from or to body tissue surrounding the electrode line, wherein the
at least one electrode is positioned in the region of the
three-dimensional shaping of the electrode line.
Description
The invention concerns an intravascular electrode line of a
configuration suitable for fixing in a blood vessel.
BACKGROUND OF THE ART
Electrode lines or leads, which for example are inserted into blood
vessels or through blood vessels into a chamber of a heart, are
basically known. Such electrode lines generally carry electrodes
which serve to deliver electrical pulses to body tissue surrounding
the electrode line or lead, or to receive electrical signals from
the body tissue. For example, stimulation electrodes for cardiac
pacemakers are known.
It is also known for electrode lines to be deformed
two-dimensionally, for example in a coil form, so that the outer
arcs of the electrode line formed as a coil bear against the walls
of a vessel and thus provide the electrode line with a hold in the
vessel, as is shown for example in U.S. Pat. Nos. 4,374,527,
5,922,014 and 5,925,073. An electrode line which is
three-dimensionally deformed in such a way that it provides a hold
for the line in the atrium of a heart is known for example from
U.S. Pat. No. 5,995,876. In that case the electrode line is shaped
in such a way that electrodes bear against the myocardium in the
region of the atrium.
In addition, U.S. Pat. Nos. 5,387,233 and 6,129,750 disclose
electrode lines which are wound in a helical configuration and
which are adapted for insertion into a blood vessel, more
specifically into the coronary sinus, and bear with the turns of
the helix against the vessel walls of the coronary sinus.
The present invention primarily relates to intravascular electrode
lines, that is to say electrode lines for elongate blood vessels
such as arteries or veins. In contrast to for example heart
chambers with their bulging recess configurations which provide a
hold for a line, the task involved in providing a hold for
electrode lines in elongate blood vessels is a different one. The
walls of the blood vessels should as far as possible not be
damaged, and in addition the blood vessel should still remain
capable of passing blood and not blocked by the electrode line.
Taking the above-depicted state of the art as its starting point,
the object of the invention is to provide an intravascular
electrode line of an alternative configuration affording a hold
therefor.
SUMMARY OF THE INVENTION
In accordance with the invention that object is attained by an
electrode line or medical lead of the kind set forth in the opening
part of this specification, which involyes a three-dimensional
shaping at least in a portion and there includes an elongate hollow
space, wherein the lead has at least two line (sub)-portions with a
different pitch direction in respect of the longitudinal direction
of the hollow space, or a different winding direction of the
lead.
The electrode lines known from U.S. Pat. Nos. 5,387,233 and
6,129,750, like the electrode line according to the invention, are
also shaped three-dimensionally, namely in a helical configuration,
wherein the helix respectively formed by the electrode line
encloses a hollow space. In those known electrode lines, the
electrode line in the region of the helix involves throughout the
same pitch direction or the same winding direction. The electrode
line according to the invention differs from that state of the art
in that the pitch direction or winding direction of the electrode
line in the three-dimensionally deformed condition changes at least
once. That affords in particular the manufacturing advantages which
will be discussed in greater detail hereinafter. In addition
torsional effects which occur in the known electrode lines which
are deformed in a helical configuration upon stretching or
upsetting of the helix portion can be specifically compensated.
A very simple and therefore preferred electrode line has two line
portions shaped in a helix-like manner, involving opposite pitches.
In the case of such an electrode line, the different pitch
direction thus arises out of the opposite direction of rotation of
the underlying helix. Such an electrode line can be easily
manufactured by firstly being shaped in the manner of a triangle
which is open at one side. Then, the triangle formed in that way is
wound around a cylinder. That gives an electrode line which is
simple to produce and in which torsional forces upon stretching or
upsetting of the deformed line portion are compensated to the best
possible extent.
In an alternative preferred embodiment the development of the
electrode line which includes a hollow cylinder is not triangular
but .OMEGA.-shaped. An essential feature of that .OMEGA.-shape is a
kind of negative pitch or undercut, as is described in the specific
description hereinafter with reference to the drawing. That
negative pitch or undercut configuration provides that the diameter
of the enclosed hollow space increases so that the correspondingly
shaped electrode line is wedged when subjected to a tensile loading
in a blood vessel in the form of a hollow cylinder as, when a
tensile loading is applied, the electrode line presses more firmly
against the wall of the vessel. The fixing of the electrode line
thus becomes firmer when a tensile loading is applied. If in
contrast the pitch of the pre-shaped line portions is only
positive--irrespective of the direction of rotation of the
underlying helix--the enclosed hollow space decreases when a
tensile loading is involved so that the wedging action does not
occur. Besides arising out of the direction of rotation of the
respective underlying helix, a different pitch direction can thus
alternatively or additionally also arise out of the fact that the
line portions enclosing the hollow space also have portions in
which the component in respect of extent of the electrode line, in
parallel relationship with the longitudinal direction of the
enclosed hollow space, has different signs, accordingly a negative
or a positive pitch.
Further advantageous alternative configurations concern
introduction of the electrode line variants into a blood vessel.
That is made easier by virtue of the fact that the electrode line
is stretched as far as possible in the introduction operation and
assumes its three-dimensional configuration only when it has
reached its destination. An alternative configuration which
advantageously permits that to be done involves a
three-dimensionally pre-shaped electrode line which, by virtue of
the introduction of a stiletto into the lumen enclosed by the
electrode line, can be so stretched that it is easy to introduce
into blood vessels.
In another alternative variant, the electrode line is of a
flexurally soft nature and has a lumen. A controllable guide wire
for example can be inserted into that lumen in order in that way to
be able to targetedly control the electrode line upon introducing
it into a blood vessel. When the electrode line has reached the
destination, instead of the control wire it is possible to
introduce into the lumen for example a three-dimensionally
pre-shaped stiletto, for example in the form of a
three-dimensionally pre-shaped spring wire. That then imposes its
shape on the flexurally soft electrode line.
A further alternative configuration involves an electrode line
which has a stiffening coil of elastic material which is formed
into a plurality of turns. Provided in the lumen of that electrode
line is a chord or fiber or filament which is fixed with its distal
end to the electrode line. In that way, applying a pulling force to
the fiber gives an upsetting force in the electrode line. The coil
is of such a configuration that when a pulling force is applied on
the fiber the electrode line flexurally deflects from its
longitudinal direction and assumes a predetermined
three-dimensional shape. When suitable materials are used, that
shape can be fixed so that the electrode line retains the
three-dimensional deformation when the pulling force by way of the
fiber is relaxed.
Yet another embodiment is distinguished by a memory metal element
which for example has a per se known titanium alloy which, when a
triggering temperature is exceeded, changes its shape from a first
shape to a second shape. That memory metal element is such that its
first shape corresponds to a substantially straight electrode line
which permits easy insertion of the electrode line while the second
shape of the memory metal, after the triggering temperature is
exceeded, results in a three-dimensionally deformed electrode line.
Advantageously, it is possible to provide a heating element for
heating the memory metal element to the triggering temperature if
the body temperature is not sufficient to reach the triggering
temperature. If the body temperature is sufficient to reach the
triggering temperature at which the memory metal changes its shape,
it is possible to provide cooling means, alternatively the
electrode lines can also be introduced in the cooled condition so
that during and after introduction into the blood vessel it slowly
warms up and finally reaches the triggering temperature.
Advantageously the electrode line in the region of its
three-dimensional shaping carries at least one electrode in such a
way that the electrode bears against the wall of a respective blood
vessel.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will now be described in greater detail by means of
embodiments with reference to the Figures in which:
FIGS. 1a and b show a first embodiment of a three-dimensionally
deformed electrode line and a sketch showing how this embodiment
can be produced,
FIGS. 2a and b show an alternative embodiment and a sketch showing
how the alternative embodiment can be produced,
FIGS. 3a through d show an embodiment of an electrode line which is
deformable by upsetting a stiffening coil,
FIGS. 4a and b show a portion of a flexurally soft electrode line
which is deformable by insertion of a pre-shaped stiletto, and
FIGS. 5a through c show a three-dimensionally pre-shaped electrode
line which can be straightened by inserting a straightening
stiletto.
DETAILED DESCRIPTION OF THE INVENTION
FIGS. 1a and 2a each show in diagrammatic form a
three-dimensionally shaped portion of an electrode line 10. In the
case of FIG. 1a the three-dimensionally shaped portion is composed
of two sub-portions 12 and 14 which are each of a helical
configuration and which differ from each other by virtue of the
pitch or the winding direction of the helix. The
three-dimensionally shaped portion of the electrode line, shown in
FIG. 1a, can be produced by the electrode line 10 firstly being
shaped in a triangular configuration, as is shown in FIG. 1b. Then
the triangularly shaped portion of the electrode line 10 is wound
around a cylinder 16, as indicated in FIG. 1b. The two legs of the
triangle which are each formed by a respective portion 18 and 20 of
the electrode line in that way afford the two sub-portions 12 and
14 of the three-dimensionally shaped electrode line of FIG. 1a.
The three-dimensionally shaped electrode portion 22 shown in FIG.
2a can be produced in a similar manner to that described
hereinbefore, by a procedure whereby the electrode line 10' is
firstly pre-shaped in an .OMEGA.-shape, as indicated in FIG. 2b,
and the .OMEGA.-portion is wound around a cylinder 16'. This
provides that the three-dimensionally shaped portion 22 of the
electrode line 10' shown in FIG. 2a, in the development of the
cylinder enclosed by the line portion, is .OMEGA.-shaped. That
therefore affords line portions 24 whose components of extent in
parallel relationship with a longitudinal axis 26 of the enclosed
hollow space 16' involve a different orientation or sign-related
direction, from the rest of the line portions. The line portions 24
`go back` and thus have a negative pitch and accordingly afford
undercut configurations.
Besides the manufacturing variants illustrated, it is also possible
to envisage others. FIGS. 1a and 1b and FIGS. 2a and 2b serve in
particular to describe the relationship between the respective
three-dimensional shape of the shaped electrode line 10 or 10'
respectively and the corresponding flat representation by virtue of
developing the cylinder enclosed by the electrode line. The hollow
space enclosed by the electrode line in the three-dimensionally
shaped portion does not necessarily have to be cylindrical, it can
also be in the form of a truncated cone or any other elongate
shape, for example a prism shape.
FIGS. 3 through 5 show different embodiments of electrode lines
which in the straightened form can be introduced into a respective
blood vessel and can assume their three-dimensional shape after
insertion.
The electrode line 10 in FIG. 3 includes a sleeve 30 (only
indicated in FIG. 3a) and within the sleeve 30 a metal coil 32 and
a fiber or filament 34 which is arranged in a lumen enclosed by the
metal coil 32 and which at its distal end is connected by way of a
connecting plate 36 to the metal coil 32.
FIG. 3b shows a plan view of a portion of the metal coil 32 and
FIG. 3c shows a side view of the portion of the metal coil 32. It
will be seen that the individual turns of the metal coil 32 are
spaced from each other and that the strip material which
constitutes the metal coil 32 is wider at each of the locations 38.
By virtue of pulling on the fiber 34 the metal coil 32 is reduced
in length until the turns of the metal coil 32 bear against each
other; see FIG. 3d. As the strip material of the metal coil 32 is
widened at each of the locations 38, the shortened or upset metal
coil 32 does not retain its elongatedly straight shape but assumes
the flexed condition shown in FIG. 3d. On the basis of the
principle shown in FIG. 3, the turns corresponding to the metal
coil 32 can be designed in such a way that an electrode line
assumes any three-dimensional curvatures by virtue of pulling on a
fiber inserted therein. Without a pulling force being applied to
the fiber the electrode line is straight and flexurally soft and
can be easily introduced into the blood vessel, as indicated in
FIG. 3a.
FIGS. 4a and 4b are based on an initially flexurally soft electrode
line 10 into which, after placement in a blood vessel, a pre-shaped
spring steel wire 40 can be introduced in the manner of a stiletto,
as is indicated in FIG. 4a. After introduction of the spring steel
wire 40 the electrode line 10 assumes the shape which is
predetermined by the spring steel wire 40; see FIG. 4b.
The electrode line 10 shown in FIGS. 5a and b is as such already
three-dimensionally pre-shaped and can be straightened by the
introduction of a suitably stiff stiletto 50, as is indicated in
FIG. 5b. The stiletto 50 can also be moderately bent in order to
provide for controlling the end of the electrode line 10. After
placement of the electrode line 10 the stiletto 50 is removed
again, see FIG. 5c, and the electrode line 10 assumes its
originally predetermined, three-dimensional shape. Pre-shaping of
the electrode line 10 in FIG. 5 is effected by firstly a wire being
bent to correspond to the desired pre-shaping of the electrode
line, similarly to the spring steel wire 40 in FIG. 4, and by the
metal coil of the electrode line then being pushed on to the
pre-shaped wire. Similarly to the situation in FIG. 4, the metal
coil assumes the shape of the bent wire. The metal coil together
with the bent wire is then heated to incandescence (annealed) so
that the structure of the metal coil is changed and the metal coil
retains its pre-shaping even without the bent wire. After annealing
of the metal coil it can also be quenched, that is to say suddenly
cooled, so as to give a spring-elastic metal structure.
* * * * *